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Regulation Regulatory Requirements Food and Drug Administration (FDA)

Hogan Lovells

FDA clarifies 510(k) clearance transfer rules in new Q&A guidance

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Troutman Pepper Locke

California and Denver Impose New Restrictions on Nicotine Analog Products

Troutman Pepper Locke on

In what appear to be the first restrictions of their kind, the state of California and the city and county of Denver have adopted bans on flavored tobacco products that cover not only products containing tobacco and nicotine,...more

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